This function focuses on evaluating chemical substances that may migrate from packaging materials, manufacturing equipment, or container closure systems into APIs or drug products. E&L studies ensure patient safety, product quality, and regulatory compliance throughout the product lifecycle.
Key Deliverables
- Extractables Studies: Identifying potential leachable chemicals from packaging materials or equipment under exaggerated conditions.
- Leachables Testing: Measuring chemicals that actually migrate into the product under real-time storage or manufacturing conditions.
- Analytical Techniques: Using GC-MS, LC-MS, ICP-MS, and other advanced analytical methods for sensitive detection and quantification.
- Risk Assessment: Evaluating potential toxicity and regulatory impact of detected extractables and leachables.
- Regulatory Support: Preparing reports and documentation for submission in IND, NDA, ANDA, DMF, and container closure system evaluations.
- Guidance for Packaging & Manufacturing: Providing recommendations to mitigate risks, select appropriate materials, and ensure product safety.